BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOM BASE ASSEMBLY

    MDR report key: 4092834 · Received August 21, 2014

    Report

    Report Number
    1222895-2014-00019
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    July 25, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO INVOLVING THE SAME PRODUCT FROM THE SAME FACILITY. CROSS REFERENCE WITH MFR REPORT NUMBER: 1222895-2014-00017 (B)(4). IT WAS REPORTED THAT THERE IS AN ISSUE INVOLVING A CRWPBS (PHANTOM BASE ASSEMBLY). THE ISSUE WAS DESCRIBED AS FOLLOWS: THE SURFACES OF THE SYSTEM ARE "STRONGLY" CORRODED, COLOR SCALING ALMOST COMPLETELY GONE. THEREFORE, THE SYSTEM IS VERY SLUGGISH. THE SYSTEM WAS PURCHASED IN (B)(6) 2014. INTEGRA HAS CONFIRMED THE STANDARD PROCESS TO THE HOSPITAL ON CLEANING AND AUTOMATIC WASHING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504530 PHANTOM BASE ASSEMBLY NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1